TEC 7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-22 for TEC 7 manufactured by Datex-ohmeda, Inc.

Event Text Entries

[133754780] During a coronary artery bypass graft procedure, the patient had just been placed on cardiopulmonary bypass when it was noted that the arterial blood looked dark. The patient was immediately taken off bypass. It was determined by the perfusionist that the g. E. Isoflurane vaporizer was inoperable, and oxygen was not being delivered to the oxygenator. The isoflurane vaporizer was not utilized for the remainder of the case. The device was handed over the facilities bioengineer for testing. He observed that the vaporizer would not stay locked on the heart lung pump mount. Notably, for safety reasons the device will not flow any gas if it does not remain locked. The device was taken to an anesthesia machine and it locked correctly and the output was verified with a g. E. Technician. All test passed, and the vaporizer output gas flow was determined to be within the limits set by g. E. No issues were found with the operation of the device. The mounting bracket in question was removed and realigned and then the vaporizer was reattached. The device latch remained latched and the vaporizer performed as expected on the heart lung mount. Manufacturer response for isoflurane vaporizer, ge isoflurane vaporizer (per site reporter). Our in house biomed engineer contacted g. E. Representative and discussed the issue and testing performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8267000
• MDR Report Key: 8267000
• Date Received: 2019-01-22
• Date of Report: 2019-01-13
• Date of Event: 2018-12-23
• Report Date: 2019-01-13
• Date Reported to FDA: 2019-01-13
• Date Reported to Mfgr: 2019-01-22
• Date Added to Maude: 2019-01-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TEC 7
• Generic Name: VAPORIZER, ANESTHESIA, NON-HEATED
• Product Code: CAD
• Date Received: 2019-01-22
• Lot Number: BEGH 00213
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DATEX-OHMEDA, INC
• Manufacturer Address: 3030 OHMEDA DRIVE MADISON WI 53718 US 53718

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-22